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Search / Trial NCT05932615

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

Launched by ABBOTT MEDICAL DEVICES · Jul 5, 2023

Trial Information

Current as of July 24, 2025

Enrolling by invitation

Keywords

Navitor Heart Disease Transcatheter Aortic Valve Implantation (Tavi) Aortic Stenosis Cardiovascular Diseases

ClinConnect Summary

ENVISION is a prospective, multi-center clinical investigation at up to 115 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will register subjects in two separate cohorts: (1) a pivotal randomized cohort and (2) a valve-in-valve (ViV) cohort.

The objective of the pivotal randomized cohort is to evaluate the safety and effectiveness of the Navitor TAVI System for...

Gender

ALL

Eligibility criteria

  • Key Inclusion Criteria:
  • 1. Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:
  • 1. Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and \< 8% at 30 days
  • 2. Low risk: estimated risk of overall surgical mortality \< 3% at 30 days Estimated risk of overall surgical mortality includes consideration of the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator
  • 2. New York Heart Association (NYHA) Functional Classification of II, III, or IV
  • 3. Degenerative aortic valve stenosis
  • Key Exclusion Criteria:
  • 1. In the opinion of the Investigator, life expectancy is less than 2 years
  • 2. Evidence of an acute myocardial infarction \[defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation\] within 30 days prior to index procedure
  • 3. Untreated clinically significant coronary artery disease requiring revascularization
  • 4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure
  • 5. Blood dyscrasias as defined: leukopenia (WBC \< 3000 mm3), acute anemia (Hb \< 9 g/dL), thrombocytopenia (platelet count \< 50,000 cells/mm³); history of bleeding diathesis or coagulopathy
  • 6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
  • 7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
  • 8. Renal insufficiency (creatinine \> 3.0 mg/dL or eGFR \< 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
  • 9. Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.)
  • 10. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
  • 11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)
  • 12. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT.
  • 13. Severe ventricular dysfunction with LVEF \< 30% as measured by resting echocardiogram
  • 14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
  • 15. Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)
  • 16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
  • 17. Minimum access vessel diameter of \< 5.0 mm for small FlexNav Delivery System and \< 5.5 mm for large FlexNav Delivery System
  • 18. Eccentricity ratio of the annulus \< 0.73
  • Additional Exclusion Criteria for Pivotal Randomized Cohort
  • 1. Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk
  • 2. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
  • 3. Mixed aortic valve disease
  • 4. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT
  • 5. Inadequate aortic valve calcification
  • 6. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
  • Additional Exclusion Criteria for ViV Cohort
  • 1. Failing valve has moderate or greater paravalvular regurgitation.
  • 2. Known severe prosthesis-patient mismatch
  • 3. Failing valve is unstable, rocking, or not structurally intact.
  • 4. Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic.
  • 5. Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve.
  • 6. Increased risk of coronary obstruction by prosthetic leaflets of the index valve

About Abbott Medical Devices

Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.

Locations

Ann Arbor, Michigan, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Cincinnati, Ohio, United States

Toronto, Ontario, Canada

Portland, Oregon, United States

Gainesville, Georgia, United States

Thousand Oaks, California, United States

Norfolk, Virginia, United States

Stanford, California, United States

Washington, District Of Columbia, United States

Memphis, Tennessee, United States

New York, New York, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Chicago, Illinois, United States

Miami, Florida, United States

Dallas, Texas, United States

Houston, Texas, United States

Seattle, Washington, United States

Kansas City, Missouri, United States

Buffalo, New York, United States

Kalamazoo, Michigan, United States

Charlottesville, Virginia, United States

Cleveland, Ohio, United States

Tallahassee, Florida, United States

Pittsburgh, Pennsylvania, United States

Mineola, New York, United States

Little Rock, Arkansas, United States

Midland, Michigan, United States

Phoenix, Arizona, United States

New Orleans, Louisiana, United States

Atlanta, Georgia, United States

Wausau, Wisconsin, United States

Tulsa, Oklahoma, United States

Evanston, Illinois, United States

Manchester, New Hampshire, United States

Indianapolis, Indiana, United States

Albany, New York, United States

Largo, Florida, United States

Plano, Texas, United States

Wynnewood, Pennsylvania, United States

La Jolla, California, United States

Greenville, North Carolina, United States

Milwaukee, Wisconsin, United States

Asheville, North Carolina, United States

Vancouver, British Columbia, Canada

Morristown, New Jersey, United States

Wichita, Kansas, United States

Calgary, , Canada

Sioux Falls, South Dakota, United States

Fontana, California, United States

New York, New York, United States

Montréal, Quebec, Canada

Orlando, Florida, United States

New York, New York, United States

Saint George, Utah, United States

Wichita, Kansas, United States

Austin, Texas, United States

Mechanicsburg, Pennsylvania, United States

Evanston, Illinois, United States

La Jolla, California, United States

Honolulu, Hawaii, United States

Oak Lawn, Illinois, United States

New York, New York, United States

Columbus, Ohio, United States

Montréal, Quebec, Canada

Saint John, , Canada

Denver, Colorado, United States

Evanston, Illinois, United States

Saint George, Utah, United States

Patients applied

0 patients applied

Trial Officials

Barathi Sethuraman

Study Director

Abbott Structural Heart

Michael Reardon, MD

Study Chair

The Methodist Hospital Research Institute

Azeem Azeem, MD

Study Chair

Montefiore Medical Center

Bassem Chehab, MD

Principal Investigator

Ascension Via Christi Hospitals Wichita, Inc.

Ibrahim Sultan, MD

Principal Investigator

The University of Pittsburgh Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported